Jobbeschreibung
You will be part of the Technical Lab Support Team mainly on-site focused on a comprehensive clinical trial management in the variety of indications. In this team you will be mainly involved in operational and organizational qualification/validation and life-cycle management of laboratory equipment and calibration activities including management of deviations, CAPAs and changes in order to conduct the business activities under GCLP requirements and BSL2/3 containment.
Responsibilities as a Process Specialist (m/w/d) in the Technical Lab Support department:
- Provide coordination and oversight and ensure GCLP compliance regarding equipment qualification, calibration and maintenance, Change management as well as Deviation & CAPA management
- Validation Owner for computerized systems
- Ensure timely completion of processes and workflows
- Manage equipment SOPs lifecycle as well as qualification and validation documents
- Supports the implementation of new quality requirements
- Participation in regular meetings locally and globally in order to ensure harmonization of procedures and processes
- Support preparation of audits / inspections (documentation and logistics)
- Escalation of EHS and quality issues.
Requirements and needed knowledge:
- Bachelor's degree in biology, biochemistry, life science or a similar degree program.
- At least three years of professional experience in the relevant field, ideally in the qualification, calibration and maintenance of GCLP compliance equipment
- Experience of working in a GxP environment
- Very good written and spoken German and English language skills
- Good computer skills (especially MS-Office package).
- Fair payment
- Special payments (e.g. Christmas, vacation)
- Binding to c ollective agreement (HessenChemie)
- Gym allowance
- Company pension scheme
- Bike leasing (plus employer subsidy)
- High flexibility in place & time of work
- Professional development.